Information about Military and Civilian Biodefense/Terrorism Countermeasures, vaccines, laws and policies

December 30, 2006

Anthrax vaccinations expected to resume in late January

Lawyer for six DOD employees vows to try to stop program

By Jeff Schogol, Stars and Stripes

ARLINGTON, Va. - Mandatory anthrax vaccinations for some troops are expected to resume in late January, said Defense Department spokesman Maj. Stewart Upton on Friday.

Meanwhile, an attorney representing six Defense Department employees who refuse to take the vaccine has vowed that he will try to stop the mandatory vaccination program.

In October, the Defense Department announced it was making anthrax vaccinations mandatory for U.S. troops on the Korean peninsula and in the U.S. Central Command area of operations.

At one time, shots were mandatory for all troops. But in 2004, a federal judge halted the inoculations after finding the Food and Drug Administration had made mistakes in determining the drug was safe.

The judge allowed the Defense Department to resume the shots on a voluntary basis, but only about half of U.S. troops opted to get vaccinated, prompting the department to make the vaccinations mandatory again for troops downrange and in South Korea.

On Dec. 6, the Defense Department issued guidelines for implementing the mandatory vaccinations to each branch of the service, Upton said in an e-mail to Stars and Stripes.

Under the guidelines, the services have 45 days to get back to the department on their implementation plans, Upton said. "Once the implementation plans are approved, the service may commence mandatory vaccination for the applicable categories of personnel," Upton said. "This is expected in late January."

But Mark Zaid, a Washington, D.C., attorney who filed a class-action lawsuit against the DOD over the program, has vowed to try to block mandatory shots in court.

"We are well-prepared to challenge the Defense Department each time it exercises poor judgment involving AVIP (Anthrax Vaccine and Immunization Program), and will file a Temporary Restraining Order in January to attempt to prevent any unlawful inoculations, " Zaid said in a Friday e-mail to Stripes.

Zaid has claimed that the anthrax vaccine is potentially unsafe, but the Defense Department maintains the vaccine is safe and effective. "Like all vaccines, anthrax vaccine can cause soreness, redness, itching, swelling and lumps at the injection site," Defense health officials said in October. "Beyond the injection site, some will notice rashes (an average of 16 percent), headaches (14 percent to 25 percent), joint aches (12 percent to 15 percent), malaise (6 percent to 17 percent), muscle aches (3 percent to 34 percent), nausea (3 percent to 9 percent), chills (2 percent to 6 percent), fever (1 percent to 5 percent). These symptoms usually go away after a few days. The rates of these reactions are similar to those experienced by recipients of other common vaccines."

But medically retired Air Force Capt. Kelli M. Donley has said she believes the vaccine shrunk her cerebellum, the part of her brain that controls muscle movement.

"I've had a litany of medical tests. It's not diabetes. It's not cancer. It's not - Lyme disease didn't cause it. I mean, I've been poked and prodded. I've had spinal taps. I've had genetic tests. Everything possible medically has been ruled out," Donley said at an October symposium about the resumption of mandatory anthrax vaccinations.

'They don't stand by me now'

PLYMOUTH -- Bradley Brown seemed to be perfect for the Army. He was strong and athletic, having run track and played football and basketball at LaVille High School.

After his graduation in May 2004, his ambition was to serve his country.

He hoped to make it a career-long commitment. He would qualify for the G.I. Bill and when, honorably discharged, go into some form of law enforcement.

After a series of short factory jobs, Brown enlisted in the Army on Nov. 9, 2005.

"Being in wartime, it made me nervous," said his mom, Sheila Annis. "But I knew he always wanted to serve our country, and I supported him in his decision."

Brown passed the physicals in the MEP Center in Chicago with flying colors, she said.

Sent to Fort Sill, Okla., he trained with fellow soldiers doing the routine things -- marching with 100-pound backpacks and qualifying on obstacle courses.

On Dec. 3, 2005, Brown went to the Army doctor, complaining of severe back strain.

Brown said the doctor gave him an anti-inflammatory nonsteroid prescription for Naproxen and shot dye into his veins for radiographic (X-ray) studies.

The results had not come back by Dec. 8, 2005, when the troops went home on Christmas leave.

Brad was sick. He was dizzy, had hot flashes, pain and a sore throat.

On Dec. 19, his mother took him to the emergency room in the Saint Joseph Regional Medical Center, Plymouth, where he was initially diagnosed with a urinary infection and strep throat. He said he was given an I.V. with antibiotics and sent home.

By Christmas Eve, Brown was no better. Back at the hospital, a kidney infection was suspected, and he was hydrated with a stronger dose of meds, he said.

The blood vessels in his eyes ruptured. Back in the emergency room, the doctor on duty diagnosed Brown's condition as acute renal failure, as much as 75 percent."Where do you want to go?" the E.R. doctor asked him.

"What do you mean? Why?" Brown said.

"You're dying," the doctor replied.

Hours later that night, two days after Christmas, the young soldier was taken by ambulance to Indiana University Medical Center, Indianapolis. His fiancée, Lindsay Burnside, a junior at Saint Mary's College, rode in the ambulance with him. His mom followed behind.

The tissues in his body swelled. During the ride to the Indianapolis hospital, his blood pressure shot up to dangerous heights. Brown, heavily sedated with morphine, doesn't remember the first four days of his hospital stay, from Dec. 27 to Jan. 9. He was in complete kidney failure.

Dr. Richard Hellman, an IU kidney specialist, did a biopsy and has said Brown will need a kidney transplant.

He says he has some stuttering and short-term memory loss. Out of work for 11 months, he finally got a job last month with the Elkhart Correctional Facility.

'The Army broke him'

At home in Plymouth, Brown and his mom can't help but feel they've been betrayed by the Army.

They say the Army ruined his kidneys and, even worse, has turned its back on him.

"The Army broke him -- my 20-year-old- son -- threw him out, sent him back to me and refuses to pay his medical expenses or give him any benefits from injuries incurred in the service," Annis said.

Given an "uncharacterized discharge," handed out to individuals during their first 180 days of military service, Brown was released from the Army on Jan. 30.

He was paid no back wages. In fact, the time he was in the hospital and the two weeks of recuperation at home were deducted from his paycheck. His mother said the family had to pay his travel expenses back to Fort Sill.She said Brown has no military medical benefits and no insurance, with the exception of Medicaid, which he will receive on Feb. 1.

Annis works in human resources for a Bremen company. To her, it is inconceivable that an employer -- in this case, the Army -- could refuse to compensate an employee whose illness or injury occurred on the company's premises.

His disease is an autoimmune disorder that can be caused by a number of things, two of which are reactions to dye used for radiographic studies and nonsteroid anti-inflammatory medication.

But the military services apparently aren't like other employers.

The U.S. Supreme Court has upheld special protections for the military, so the government can't be sued for injuries resulting from the negligence of others in the armed services.

It's called the Feres Doctrine, resulting from a 1950 case in which an Army lieutenant died in a barracks fire and his family sued for damages.The argument, basically, is that the military cannot be held to the same standards of care and safety because the preparation for war itself is a dangerous act. So the government has its own procedures for determining which claims should be upheld.

Typically, the first step would be to file a claim with the county veterans services officer.

Robert Stapan, the Marshall County veterans service officer, could not confirm whether Brown filed such a claim.

"I'm not at liberty to discuss cases," he said.

But typically, a veteran with an injury can file a claim through his office, which sends the file along to the department of Veteran Affairs, he said.

Once the VA issues its decision, appeals can be filed. Depending on the issues, he said, it may take a couple of months or a year to resolve the case.

In addition to being denied help from the military for his medical expenses, Brown also was denied access to the GI Bill. The premise was that his medical condition existed before induction, Annis said.

Debate over benefits

Brown's family doctor, Dr. Eric Tripp, disagrees strenuously.

Tripp sent a letter to the VA saying he has cared for Brown for the past 12 years and "that he did not have any previous kidney disease."

Annis said Brown has sought help from his congressman, but he received no reply. U.S. Rep. Chris Chocola lost in his re-election campaign in November. His office is closed, and his staff was unavailable for comment.

A new congressman, Joe Donnelly, doesn't take office until January.

Annis said the message she's getting is that Brown doesn't qualify for help because his injury and illness occurred so soon after his enlistment.

In its rating decision of Oct. 31, the Department of Veterans Affairs admits a connection between Brown's service in the military and his kidney disease.

But still, there is no compensation.

Brown and Annis had worked through the Amvets organization as well in filing the claim.

Feeling that the Army has turned its back on her son -- and because he was still a minor -- she has appealed the decision on his behalf.

When Annis decided to pursue an appeal, Amvets objected.

"Frankly, I think you are getting ready to mess up, and I choose not to be a part of a battle where a veteran's mother is doing the arguing," LaMonte Crenshaw, Amvets national service officer, wrote in a Nov. 15 letter.

"We are going to appeal," Annis said, "and, of course, like any other parent, I am going to represent my child."

She's following the procedures and hasn't hired a lawyer. "We're trying to do everything politically correctly," she said.

Still, she wonders how many young men and women have been damaged and discarded by the military.

"I don't know how this is allowed," she said. "I sent them a perfectly healthy child. Now we have a broken one."

Brown is maintaining some kidney function, with the help of fish oil supplements. But, at some point, it's likely he'll need a transplant, Annis said.

But Brown also is almost destitute. He says he owes on car payments and other loans, and his medical bills will amount to an estimated half-million dollars.

December 23, 2006

Mandatory anthrax vaccinations raise concerns

WASHINGTON - En route home from the Persian Gulf on a military supply ship in 2003, merchant seaman James Francis and his mates got an ultimatum: Take anthrax and smallpox vaccinations or lose your jobs.

Francis' Seattle attorney, Russell Williams, described the shipboard scene the next day off the isle of Crete as: "Wham, bam. 'Get in line. Take your shots.'"

Within days of taking the two shots, Francis' feet began to tingle and burn. When he later took the second in a series of six anthrax shots, his health slid downhill. Since then, the 45-year-old messmate from Las Vegas has fought a rare nervous system disease known as Guillain-Barre Syndrome, along with chronic pain, pneumonia and a life-threatening blood clot.

Vaccine makers are immune from lawsuits, so Francis sued the government, winning what his lawyer calls a "substantial" settlement in December 2005. Others say Uncle Sam shelled out about $2 million.

But Francis' success is unlikely to be duplicated by any soldier harmed in the massive anthrax inoculation program that's set to get under way in earnest early next year. Some 200,000 troops, who unlike private employees are barred from suing the U.S. government, will be required to take the vaccine.

The Pentagon is reviving its mandatory anthrax vaccinations despite allegations that the shots have contributed to as many as 23 deaths and sickened hundreds, and perhaps thousands, of soldiers.

On Tuesday, the Department of Health and Human Services canceled an $877.5 million contract with California-based VaxGen. Inc. for what would have been a substitute anthrax vaccine. HHS said the company missed deadlines for beginning tests on humans.

That puts even more focus on the controversial, decades-old vaccine, which has been used to inoculate 1.5 million military personnel. The Pentagon has been rocked by criticism that it has failed to adequately track whether the shots have caused diseases. Indeed, as occurred with Francis, many soldiers are injected with several vaccines on the same day, making it harder to identify the cause of illnesses.

In 2004, lawyers for sick soldiers won a court injunction blocking the mandatory shots until the Food and Drug Administration reviewed the license of Maryland-based vaccine manufacturer Emergent BioSolutions. In December 2005, the FDA declared the vaccine safe and restored the license.

But testimony from some military doctors undercuts that decision.

Dr. Limone Collins, the medical director of the Vaccine Healthcare Center at the Army's Walter Reed Army Medical Center, testified that Francis had "a rare, vaccine-associated, neuro-immunological disease," according to court papers.

Dr. William Campbell, a neurologist at the center, said the dual vaccinations afflicted Francis with a Guillain-Barre variant in which the body's immune system attacks the nervous system.

In another case, the medical director of a Vaccine Healthcare Center at Lackland Air Force Base testified last year on behalf of Nathan Torquato, a senior airman being court-martialed for using cocaine and methamphetamine to cope with muscle pain and chronic fatigue syndrome, which he blames on his anthrax shots. Helping Torquato win a lighter sentence, Dr. David Hrncir said it "appears that we are having higher numbers of people coming down with chronic fatigue syndrome as a result of this vaccine."

Despite such testimony, Pentagon health chief William Winkenwerder announced on Oct. 16 that safety questions had been resolved and that the shots would soon resume - the Pentagon now says in January - for troops deployed in the Middle East, Korea and other areas at high risk of a terrorist attack with germ weapons such as smallpox and anthrax.

Col. Randall Anderson, who runs the Military Vaccine Agency, said the Pentagon believes health risks from the anthrax vaccine "are equal to those of other vaccines" that cause illnesses in only a tiny percentage of those vaccinated.

Robert Burrows, Emergent's vice president of corporate communications, pronounced the vaccine - sold as BioThrax - to be "safe and effective" and vetted "more than any in history."

But on Dec. 13, lawyers who succeeded in stalling the mandatory program in 2004 filed suit seeking a new injunction, alleging that the FDA manipulated data from a 1950s clinical study and circumvented its rules in licensing a vaccine that was modified multiple times.

Retired Army Capt. B. David Hodge, 54, of Carlsbad, N.M., said he was serving as a chaplain when he and his Tennessee-based Army reserve unit were injected with half a dozen shots of anthrax vaccine at Fort Bragg, N.C., in 1990 before being deployed to Saudi Arabia.

Hodge said Army health care personnel refused at the time to identify the anthrax vaccine, instead calling it "Vaccine A." He said he burned with fever for several days and permanently lost feeling in his fingers. Now he fights an autoimmune disorder that's destroying his lungs. "I love my country," Hodge said. "It's my government I don't trust."

Retired Air Force Sgt. David Lyles, 32, of Mentor, Ohio, said he was injected with the shot in October 2003 at Youngstown Air Force Base.

A few minutes later, Lyles said, he fell off a stool in the base's avionics shop from anaphylactic shock and hit his head on the cement floor. Lyles, who had always been athletic, said that he recovered from the concussion but that Guillain-Barre left him walking with a cane.

"If there is a problem with the vaccine, why subject people that are helping you defend what you believe in?" asked Lyles, who also said he's lost some of his short-term memory.

An FDA system that collects adverse reaction reports for all vaccines has recorded more than 4,700 reports related to anthrax shots over the last 16 years. The number of cases, the agency says, will "inevitably be underreported."

The FDA said it has received 23 reports of anthrax vaccine-related deaths, but has seen no proof that the shots were to blame. The FDA also couldn't readily estimate the number of serious illnesses associated with the vaccinations. In the past, it has estimated 500 cases.

Dr. Meryl Nass, an internist in Bar Harbor, Maine, who has specialized in anthrax vaccine-related illnesses, says the estimates of health problems are vastly understated.

Nass said she has treated more than 500 seriously ill patients and that at least 1,500 more have phoned or sent e-mails.

Defense Department officials say several studies, including analyses of soldiers' disability claims and of post-vaccination hospitalizations, debunk the health concerns. But as recently as May, the Government Accountability Office said that the vaccine's long-term safety "has not been studied."

The Pentagon also draws criticism for giving anthrax shots with other vaccines. John Richardson, a retired Air Force pilot who has crusaded against the vaccine, charges that this is done "so they can hide which vaccine is causing the problem."

He cites the case of Rachel Lacy, a 22-year-old Army reservist who was awaiting deployment to the Persian Gulf in early 2003 when she received an anthrax shot and four other vaccinations at Fort McCoy, Wis.

A month later, she died of a pneumonia-like affliction at the Mayo Clinic in Rochester, Minn. The Pentagon called her death "a rare, tragic event that may have been related to vaccination," but said two expert medical panels couldn't identify any of the five vaccines as the culprit.

Pentagon spokeswoman Ann Ham said each reported death is similarly investigated, but none has been "causally associated with anthrax immunization alone." Anderson said a government immunization panel found no reason not to give vaccines together.

Much Pentagon data remain out of the public's reach, even though a Defense Medical Surveillance System tracks all illnesses among troops. After the National Academy of Sciences' Institute of Medicine found no proof of causal links between the vaccine and illnesses in 2002, but urged more research, the Pentagon stopped issuing quarterly analyses of BioThrax's effects. "There isn't a need for that," Anderson said.

David Geier, vice president of the Maryland-based Institute for Chronic Illnesses, and his father, Dr. Mark Geier, have analyzed the FDA's vaccine adverse reaction reports and published numerous articles on vaccine safety. David Geier said the reactions to BioThrax among healthy soldiers have been "many orders of magnitudes higher" than they've been for nearly all other civilian vaccines.

The Defense Department has said it's given the vaccine to an estimated 175,000 troops involved in the 1991 Gulf War, but said it didn't keep accurate records of who was inoculated.

A Department of Veterans Affairs advisory committee that investigated possible causes of Gulf War Syndrome, clusters of illnesses that afflicted some 200,000 war veterans, didn't rule out the anthrax vaccine as a possible cause, said Steve Robinson, a panel member and official of Veterans for America.

While Anderson said that more BioThrax studies are under way, Nass dismissed the Pentagon research as "epidemiological garbage."

For example, she cited a military study of vaccine links to optic neuritis that excluded troops who developed vision problems in their first 18 weeks in the military, even though many soldiers get their shots in boot camp. The study also omitted other soldiers not diagnosed within 18 weeks of vaccinations - shots given just before they were sent overseas where there were no ophthalmologists, she said.

The mandatory anthrax vaccine program has been beset with problems almost since deputy FDA commissioner Michael Friedman granted a 1997 Pentagon request to expand its use from protecting people against anthrax infection in skin wounds to shielding those who breathe it.

From 1998 to 2000, hundreds of active troops, reservists and National Guardsmen risked courts-martial by refusing to take anthrax shots for fear of health problems. Then the 2004 court injunction forced the Pentagon to shift to a voluntary program. About 50 percent of troops have refused the shots.

Vaccine critics note that both the VA and the Pentagon have routinely paid disability benefits to soldiers who blame BioThrax for chronic illnesses, but they list the ailments as "service-connected" without mentioning the vaccine.

Virginia attorney Richard Stevens, who has handled a number of claims, said that way, "they always have plausible deniability."

Ross: Arsenal Ideal Site For Vaccine Production - Gocom - re: ava

Ross: Arsenal Ideal Site For Vaccine Production

Arkansas Congressman Mike Ross says the latest problem in obtaining anthrax vaccine shows the need for a government-owned vaccine-production facility at the Pine Bluff Arsenal. In a letter yesterday to the secretaries of the Defense and Health and Human Services departments, Ross cited cancellation of a contract with a private company for production of anthrax vaccine.

Under Ross's proposal, the government would build a facility at the arsenal and maintain ownership, but it would be operated by a contractor.

He said the inability of independent companies to provide not only anthrax vaccines to the citizens of our country, but also numerous bio-terrorism vaccines is unacceptable.

Ross' letter cites a 1994 study by the Army Corps of Engineers concluding that the government should be responsible for vaccine production, and suggesting that a facility be put at the Pine Bluff Arsenal.

Q and A - Mandatory AVIP Resumption

Copied below are excerpts. To read the full Q and A, go to the below linkhttp://www.anthrax.mil/documents/Anthrax_QA.pdf

3) Will mandatory anthrax vaccinations resume?This will be determined shortly by the senior civilian leadership, in consultation with the Joint Chiefs of Staff.

7) Will personnel who receive vaccinations now continue their series when they return from the high threat areas?Most personnel will not continue their vaccination series when returning from the high threat areas.

8) How long will this current policy be in effect?This current policy will be in effect until the senior civilian leadership completes their full assessment of the FDA's Final Order.

16) What about all those people who received anthrax vaccinations in the past? Will they be allowed to continue the six-dose series?The Department will only give anthrax vaccinations to designated personnel, with an option to refuse,until DoD's final policy is determined.

17) What happens to those of us who have received several doses and cannot continue the series?Individuals who already started the series will be in deferral status and not receive further doses at this time.

18) What happens to those individuals who were court-martialed or given non-judicialpunishment for refusing to take anthrax vaccine?This is a matter for long-established appeals processes and the Board for the Correction of Military (or Naval) Records.

10) Besides the six scientific panels described in detail above, have any other independent scientific individuals or groups rendered opinions about anthrax vaccine?Gerald R. Burrow, MD, reviewed the health and medical aspects of the Anthrax Vaccine Immunization Program (AVIP) in 1998 before the program began. This is also discussed below. The Society of Medical Consultants to the Armed Forces (SMCAF) endorsed the anthrax vaccination program in September 1999. (moderator's note: Dr. Burrow is a gynecologist who turned down Congress's offer to testify at a hearing regarding the safety and efficacy of the anthrax vaccine, but, did send in a letter which stated that he was not an expert, and that he excepted the challenge to review the AVIP out of patriotism)

8) Do pilots who have received the anthrax vaccine have any troubles with FAA flightcertification?No, taking the anthrax vaccine has no effect on civilian or military aviation status. An excellent independent source for definitive information regarding aviation-related matters and the anthrax vaccine can be found at http://www.aviationmedicine.com/anthrax.htm. The Federal Aviation Administration reports that people vaccinated against anthrax are not disqualified from performingcivilian airman duties.

2) I heard that the vaccine used in the 1962 Brachman study isn't the same as the vaccine used today. Is that true?Yes, it is true that the current vaccine has more protective antigen (PA) in it than Brachman's vaccine formula, and also that the current vaccine is more highly purified than the vaccine used in the Brachman study. Between the time of the Brachman study and the licensing of the vaccine produced in Lansing, the conditions under which the anthrax bacteria were cultured were changed. These changes resulted in a purer, more potent vaccine. Government authorities were aware of and approved the changes at that time the license application was considered in 1970. The independent, civilian review panel advising the FDA was aware of the changes, and described them in its 1985 report. Both vaccine formulas are based on protective antigen (PA), the key protein common to all strains of anthrax.

8) Does the anthrax vaccine contain squalene?In September 2000, DoD became aware of FDA test results finding trace amounts of squalene in three out of three US vaccines tested: anthrax, diphtheria, and tetanus. The level of squalene identified by the FDA test is so minute that it is likely the result of squalene in the oil of a fingerprint not cleaned from lab glassware. The trace level of squalene found by the FDA in anthrax vaccine is less than theconcentration normally present in human blood (250 parts per billion).

1) Is the anthrax vaccination program a result of lessons we learned from the 1990-1991 Persian Gulf War?Yes. Building upon the lessons of past wars and leveraging superior technologies available today and in the future, the AVIP is one of the cornerstones of Force Health Protection. Additionally, the current world threat environment and the unpredictable nature of terrorism make it prudent to include biological warfare defense in all our force protection planning. We also learned that we need to put more effort into documentation of vaccinations in Service Members' medical records. This is the reason for the new immunization tracking systems operated by each of the military services.

3) Was the anthrax vaccine FDA-licensed at the time it was given to Gulf War veterans?Yes. The FDA licensed the anthrax vaccine in 1970. All of the anthrax vaccine administered during the Persian Gulf War was produced at the Lansing facility and release according to the lot-release test criteria for potency, purity, safety, and sterility.

3) Then why are you pursuing a next-generation anthrax vaccine?We want to explore whether a newer anthrax vaccine would be easier to produce and require fewer doses to achieve immunity. The IOM study also recognized the advantages of developing a next generation anthrax vaccine when it said, "the production, testing, and licensure of a new vaccine requiring fewer doses and producing fewer local reactions are needed."

4) What efforts does DoD have underway? Who are DoD's partners?DoD and the National Institutes of Health (NIH) have been working on a next-generation anthrax vaccine (NGAV). Specifically, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Joint Vaccine Acquisition Program (JVAP) collaborated to develop an NGAV that uses state-of-the-art recombinant technology. The NIAID collaborates with this effort by preparing theNGAV product and sponsoring human clinical phase-1 trials. The NIAID is independently pursuing multiple "recombinant protective antigen" (rPA) candidate vaccines, to identify and develop the most promising next-generation vaccine as quickly as possible. This is a parallel effort from the DoD/NIAID cooperative effort on the DoD NGAV candidate.

5) Since 1970, how many times has FDA inspected the anthrax vaccine production facility in Lansing?The FDA or the National Institute of Health (NIH) has inspected MBPI's (now BioPort's) Lansing facilities more than 50 times since 1969. Each inspection focused on one or more of three manufacturing activities: bacterial vaccines and toxoids, viral vaccines, or plasma derivatives. Examined during each of these inspections were elements common to the manufacturing of all products at the Lansing site, including the manufacture of anthrax vaccine. The anthrax vaccine manufacturingfacilities specifically have been inspected 12 times in the years following licensure. Further, the FDA did not force BioPort to close its facility and rebuild. The decision to renovate the anthrax vaccine manufacturing facilities was made in an effort to meet the demand for vaccine from the Department of Defense.

2) Did the Food and Drug Administration revoke BioPort's license to manufacture anthrax vaccine?No. BioPort's predecessor, the Michigan Biological Products Institute (MBPI), owned by the State of Michigan, approved renovations in 1995 for the Lansing facility. In 1997, the Food and Drug Administration (FDA) issued a notice of intent to revoke licenses issued to MBPI. MBPI responded within 30 days with a strategic plan for compliance to FDA standards. The manufacturer voluntarily closed the anthrax vaccine production line in January 1998 for renovation. BioPort submitted a highly detailed set of quality control documents to FDA in fall 2001. FDA approved BioPort's facilities and processes, as they relate to the manufacture of anthrax vaccine, on January 31, 2002.

5) Is there a connection between deficiencies found in the 20 February 1998 FDA Inspection Report and the fact that MBPI suspended anthrax vaccine production?There is no connection between the deficiencies found on the 20 February 1998 FDA inspection report and the fact that MBPI ceased production of anthrax vaccine in its original production suite. FDA did not order MBPI to suspend production. DoD in coordination with MBPI determined several years ago that the current production line would require scheduled renovation. The start of the renovation was contingent upon MBPI completing the production requirements needed to meet the terms of theproduction contract (DAMD 17-97-D1139). MBPI fulfilled the contract in December 1997, and the planned renovations began shortly thereafter.

6) Given the nature of the problems identified by the FDA in their inspection of the Michigan Biological Products Institute (now BioPort) in 1996, what safeguards did DoD take to assure that the anthrax vaccine is safe and effective?DoD directed that supplemental testing be done on all lots in the stockpile at MBPI produced under contract DAMD 17-97-D0003. Of these lots, only lots of vaccine that passed supplemental testing were approved for shipment and use by DoD and Coast Guard personnel.

The Facts on Squalene1) Executive SummaryA few people claim the Department of Defense (DoD) added squalene to anthrax vaccine to stretch the vaccine supply. Four civilian panels have looked into these allegations since 1999 and repeatedly found them groundless. Neither DoD nor anybody else added squalene to anthrax vaccine for our troops. DoD does not conduct illegal experiments. Details and links to independent sources of data appear below.

14) Did DoD mislead or lie to anybody about the squalene tests conducted by SRI?No. DoD truthfully and fully reported its findings at each step since May 1999, when SRI first developed its squalene test. DoD did not know of FDA's findings until they were publicly released. At the initial limit of detection of its test, 140 parts per billion, SRI found no squalene in anthrax vaccine (Spanggord et al., 2002). It was scientifically proper to say "no squalene was found to the limit of detection of theassay," which DoD officials sometimes oversimplified to say "there is no squalene present."

An influenza pandemic of the type that ravaged the globe in 1918 and 1919 would kill about 62 million people today, with 96 percent of the deaths occurring in developing countries.

That is the conclusion of a study published yesterday in the Lancet medical journal, which uses mortality records kept by governments during the time of "Spanish flu" to predict the effect of a similarly virulent outbreak in the contemporary world.

The analysis, the first of its kind, found a nearly 40-fold difference in death rates between central India, the place with the highest recorded mortality, and Denmark, the country with the lowest. The reason for the huge variation is not known, but it may reflect differences in nutrition and crowding.

If a modern Spanish flu killed all its victims in one year, it would more than double global mortality. About 59 million people now die each year.

"It is a huge, huge number," said Christopher J.L. Murray, a physician and biostatistician at the Harvard School of Public Health who headed the study. "This really took us by surprise."

One of the World Health Organization's key influenza experts, however, called the main public health implication of the study "no surprise."

"The countries most likely to be adversely affected are the ones with the least resources. This happened then, and is what is likely to happen now," said Keiji Fukuda. "WHO, as it always has done, pays a disproportionate amount of its attention and efforts toward such countries."

Historical accounts suggest that what became known as Spanish flu emerged at an Army camp in Kansas in early March 1918. It was carried to Europe by American troops, where it circulated before undergoing a change early the next fall that made it unusually lethal. It spread around the world and was brought back to the United States, where it killed hundreds of thousands of Americans in October and November 1919. It circulated until early 1920, with virtually everyone on Earth eventually exposed to the virus.

The global death toll from the pandemic is unknown. In the 1920s, it was estimated to be about 20 million. A more complete analysis in 1991 raised that to 30 million. One in 2002 said mortality "may fall in the range of 50 to 100 million."

The new study doesn't make a new estimate. Instead, it calculated the death rate in places that had good birth and death records in 1918 and 1919 in order to estimate what would happen in a larger, older and relatively more affluent world population nearly a century later.

The places with good records included most European nations, the United States, Canada, Australia, Japan and several Latin American countries. The keys to the project, however, were accurate death registries in India, Sri Lanka, Taiwan and the Philippines. They allowed Murray and his colleagues to estimate what happened among the world's non-European poor, where eyewitness accounts describe huge mortality, but few reliable statistics existed.

By far the most informative data came from India.

"The British colonial administration -- they were very good record-keepers," said Murray, who noted that India's contemporary death registries are less complete than ones from 1918.

The researchers compared the death rates during the 1918-1920 period with those in the three years before and after the pandemic. This gave an estimate of "excess mortality" during the flu years, which was assumed to be caused directly or indirectly by the virus. (Because men in countries fighting in World War I had elevated mortality in 1918, they were excluded from the calculation.) The extra deaths ranged from 0.2 percent of the population in Denmark to 7.8 percent in the Central Provinces and Berar region of India -- a 39-fold difference.

In the United States, they ranged from a low of 0.25 percent in Wisconsin to 1 percent in Colorado. (The best-known work of fiction about the pandemic, "Pale Horse, Pale Rider," is Katherine Anne Porter's account of her near-death experience during the Colorado outbreak.) Flu death rates varied greatly over short distances. Virginia's excess mortality, 0.47 percent, was well below Maryland's, 0.72 percent. Sweden's (0.66 percent) was three times Denmark's (0.2 percent).

Murray and his colleagues analyzed the death patterns and deduced that about half the variation from region to region was explained by differences in per capita income. For every 10 percent increase in income, a person's risk of dying during the pandemic fell 10 percent.

Why the poor were so vulnerable is unknown. It could have been that many were already ill with parasites or other illnesses or lacked micronutrients such as Vitamin A and zinc that are essential to immunity.

To estimate the effects of a modern Spanish flu, the researchers applied the 1918-1920 death rates to the current world population broken down by income, sex and age. They came up with a range of 51 million to 81 million deaths, with a median of 62 million.

Even though the world's population is three times what it was during the Spanish flu pandemic, the estimated mortality of a modern Spanish flu isn't three times what it was in 1918. That is mainly because per capita income is higher now -- and the higher the income, the lower the risk of dying of influenza.

The illness caused by the 1918 virus was largely untreatable. There were no antiviral drugs, no mechanical ventilators to help people breathe and no antibiotics to treat bacterial pneumonias that often set in after the viral infection. All are available now and would reduce the death toll, though some interventions would be in sort supply during a pandemic.

December 21, 2006

Which is More Dangerous to Your Health-the Flu or the FDA?

By John W. Whitehead

The flu season is here once again. During the last flu season, doctors reportedly wrote more prescriptions for the drug Tamiflu than any other flu treatment. But after recent reports about the Food and Drug Administration's reluctance to issue a warning about certain possible dangers of using Tamiflu, one has to wonder which is more dangerous-the flu or the FDA?

First approved by the FDA in 1999, Tamiflu was touted as a drug that could significantly reduce the length and severity of influenza. These claims even prompted the U.S. government to purchase 20 million doses of Tamiflu-at a cost of $2 billion-in the event that a bird flu pandemic occurred. The Pentagon followed, paying a whopping $58 million in July 2005 for treatments of U.S. troops around the world.

However, problems with Tamiflu began to surface in 2004. It was thought that the drug, which has been used by over 30 million people worldwide, was causing some of its users to manifest very unusual behavior. For example, during the 2004 and 2005 flu seasons, two teenage boys committed suicide within hours of taking Tamiflu. The 17-year-old jumped in front of a large truck on a busy road after walking outside his house barefoot and in pajamas during a snowstorm. The 14-year-old jumped to his death from the balcony of a ninth-floor flat. Later, a teenage girl was narrowly prevented from jumping to her death from a window within days of starting a course of the flu drug. By November 2005, it had been reported that 12 Japanese children had died while on the drug and that others had experienced hallucinations, encephalitis and other symptoms.

Despite these alarming reports, the FDA voted not to issue a warning about the drug's potential for causing abnormal behavior. Instead, the FDA chose to warn of Tamiflu's potential for producing skin rashes. It wasn't until reports surfaced of more than 100 new cases of delirium, hallucinations and other abnormal psychiatric behavior in children treated with Tamiflu that the FDA changed course and added a warning label in November 2006.

Over the years, the FDA has been accused of causing high drug prices, keeping life-saving drugs off the market, allowing unsafe drugs on the market because of pressure from pharmaceutical companies and censoring health information about nutritional supplements and foods.

One such critic is Dr. David Graham, Associate Director for Science and Medicine and a senior drug safety researcher at the U.S. Food and Drug Administration. In his estimation, the FDA is "responsible for 140,000 heart attacks and 60,000 dead Americans. That's as many people as were killed in the Vietnam War." His words offer an insider's perspective on the fatal role he believes the FDA played in thousands of heart attacks and deaths caused by the pain medication Vioxx-a medication the FDA approved and initially failed to warn of its potential effects. Indeed, the Vioxx debacle was brought to America's attention when Congress was presented with evidence showing that among the estimated 20 million users of Vioxx, hundreds of thousands had died or suffered heart attacks as a result of taking the drug.

Other drugs approved by the FDA and later found to cause harm include dexfenfluramine, a diet drug whose post-marketing data indicated an increased risk of pulmonary hypertension, and troglitazone, a diabetes drug that carried with it the risk of liver failure and was later pulled from the market. Yet as Graham has pointed out, "Rarely will they keep a drug from being marketed or pull a drug off the market." The delays in taking action on problematic drugs was addressed by Dr. Sidney Wolfe, director of the Public Citizen's Health Research Group, in a statement before the Institute of Medicine Committee in January 2006: "In too many instances, serious post-marketing safety problems identified by the Office of Drug Safety have not been acted upon because of resistance from FDA management and from the review division that originally approved the drug."

But the pharmaceutical companies also bear the responsibility-and the blame-for unsafe drugs being approved and put out on the market. "The FDA assumes the drug is safe and now it's up to the company to prove that the drug isn't safe," remarked Graham. "Well, that's a no-brainer. What company on earth is going to try to prove that the drug isn't safe?"

It should come as no surprise that the pharmaceutical companies have the federal government in their hip pocket. According to a 2005 report from the Center for Public Integrity, "The pharmaceutical and health products industry has spent more than $800 million in federal lobbying and campaign donations at the federal and state levels in the past seven years." In fact, no other industry has spent more money to sway public policy during that period. The report continues, "The drug industry's huge investments in Washington-though meager compared to the profits they make-have paid off handsomely, resulting in a series of favorable laws onCapitol Hill and tens of billions of dollars in additional profits."

With an estimated 200,000-plus people dying every year from prescription drugs, Graham believes "Americans and Congress should be screaming bloody murder. They should be beating on the doors of the FDA demanding change."

Constitutional attorney and author John W. Whitehead is founder and president of The Rutherford Institute. He can be contacted at johnw@rutherford.org . Information about The Rutherford Institute is available atwww.rutherford.org

The cancellation of a high-profile contract to produce 75 million doses of a new anthrax vaccine leaves federal health officials years away from a replacement for the version now in use but could raise the prospects for an alternative being developed by a British competitor.

VaxGen of Brisbane, Calif., was scheduled to begin delivering a new anthrax vaccine this year, but after delays and technical problems, the Department of Health and Human Services voided the $877.5 million contract Tuesday. The department has not announced plans to replace it, but an alternative version being developed by Avecia of Manchester, England, is being tested, and the National Institutes of Health is expected to award contracts next year for research into advanced vaccines.

The VaxGen contract was the largest piece of the Bush administration's $5.6 billion Project BioShield, which seeks to develop modern vaccines and drugs to counter chemical, biological, radiological or nuclear threats.

"The first thing to do, on HHS's part, is to explain why this failed," said Tara O'Toole, director of the Center for Biosecurity at the University of Pittsburgh Medical Center. "All of the companies are wondering, does this mean that HHS is an unreliable partner, or that this was just kind of bad luck?"

HHS canceled the contract after VaxGen missed its deadline Monday to begin human testing because of concerns at the Food and Drug Administration about the product's reliability. Agency officials declined to elaborate on the reasons for the cancellation.

VaxGen was to develop a replacement for a version of the vaccine currently used by the military and made by Emergent BioSolutions of Gaithersburg. That drug must be administered over 18 months in six shots and has been subject to controversy. Some soldiers have resisted being vaccinated and others have complained about side effects, but the FDA has said the drug is safe.

HHS had hoped that VaxGen's vaccine could be produced more quickly in an emergency and administered over a shorter period of time. "It just illustrates the uncertainty that surrounds developing a vaccine. Even in the best of circumstances, it's a risky undertaking," said Robert Kadlec, the former director for biodefense on the White House's Homeland Security Council. "But when you put it in the hands of a company that hasn't had a proven product, it's even chancier."

It is unclear how soon any of the alternatives could be produced. Emergent is working on improvements to its vaccine, including halving the number of shots required and extending its shelf life beyond three years, a company spokesman said. The U.S. Army Medical Research Institute of Infectious Diseases plans to spend $14 million in fiscal 2007 researching anthrax vaccines as well as treatments and diagnostic tools.

Avecia, which has an NIH contract to develop a vaccine, may be the closest to an alternative. The company has produced some preliminary data from human tests, Michael Kurilla, director of the Office of Biodefense Research Affairs at NIH, said. "So far the vaccine has been demonstrated to be safe," Kurilla said. But those human trials are not completed and the FDA will review the results, he said. It is unclear how long it would take for the product to be ready for wide distribution.

"There are still a number of specific actions you have to do in terms of bringing a product to commercial-scale production," Kurilla said.

In June, Avecia was awarded a $4 million grant from the National Institute of Allergy and Infectious Diseases to develop another version of the vaccine that would not need refrigeration. "That is much earlier in the pipeline," Kurilla said. An Avecia spokesman did not return a call for comment.

The NIH is also spearheading research on a third generation of the vaccine. That version could be stored at room temperature, would require fewer doses, and would not require a needle, Kurilla said. One or more contracts will be awarded next year, he said. "This is not something that is going to be a short-term event," he said.

What demise of anthrax vaccine contract means for VaxGen, U.S.

The termination of VaxGen's $877.5 million contract for an improved anthrax vaccine may force the company to severely cut costs and leaves the government's ability to develop the vaccine in the near future uncertain, several industry experts said Wednesday.

The most immediate impact of the U.S. Department of Health and Human Services's decision Tuesday to cancel the contract -- the biggest yet under President Bush's Project BioShield anti-terror effort -- will be felt by Brisbane-based VaxGen.

VaxGen's stock price rose 2 cents to $1.47 at the close of trading Wednesday on the Pink Sheets, a private listing service. But the company's future prospects appear troubled in light of the canceled contract, which called for it to deliver 75 million doses of the vaccine.Although VaxGen spokesman Lance Ignon declined to comment on how VaxGen plans to respond to the government's action, one option would be to exercise its right to appeal the contract termination. However, based on his experience helping companies with federal contracts, ``I think the probability is low of a successful appeal,'' said David Hoffmeister, a partner with law firm Wilson Sonsini Goodrich & Rosati.

Most likely, VaxGen will have to dramatically cut costs and consider a merger or other partnership with another firm to raise cash, according to Sharon Seiler, an analyst with investment bank Punk, Ziegel, who owns VaxGen stock.

``With the contract gone, we expect VaxGen to downsize,'' Seiler concluded in a note to her clients. That might include selling some of VaxGen's assets, including its vaccine manufacturing plant in South San Francisco, she said.

The contract was canceled because federal officials said VaxGen failed to meet a deadline Monday to begin a test of the vaccine in people. The company had been prevented from starting the test by the U.S. Food and Drug Administration, which feared the vaccine was not sufficiently stable to get usable results from the test.

Because the $877.5 million was to be paid only after VaxGen delivered 75 million doses of the vaccines, the company has been surviving on its own money and on previous government grants to begin developing the vaccine. It currently has about $50 million in cash, Seiler estimated, and the government has threatened to make it pay a penalty for not delivering the vaccine it promised.

Department of Health and Human Services spokesman Marc Wolfson said his agency's ability to collect such penalties is common under federal contracts.

``If we go out and buy the same product that we were going to buy from VaxGen and it comes in at a higher cost, the company that is terminated is liable for that excess cost,'' Wolfson said.

Several companies -- including Dynavax Technologies of Berkeley and Avecia of England -- have gotten much smaller federal grants to begin developing next-generation anthrax vaccines. However, it remains to be seen whether any of them could take over where VaxGen left off.

Officials with Avecia, which had bid unsuccessfully on the contract VaxGen won, could not be reached for comment Wednesday. But Gary Van Nest, Dynavax's vice president of preclinical research, said it was unlikely his company could take on the contract.

``Obviously, we're going to be talking to the government to see what's the opportunity,'' he said. However, he added, ``there is no way in the short term we could do 75 million doses.''In her note to her clients, Seiler doubted whether any other company could deliver that many doses in the near future.

``We don't think that's going to happen any time in the next several years, if ever,'' she said.Convincing companies to even bid on a reopened vaccine contract could prove tough, others said. Many biotech firms dislike the federal government's myriad rules and have shied away from such contracts in the past because they can't afford waiting to get paid until they have delivered their drugs.

On Tuesday, Bush signed into law the Pandemic and All-Hazards Preparedness Act, favored by many biotech executives, which will make it easier for companies to get partial payments while they are still developing their drugs.

But given VaxGen's experience, it's unclear if that law can overcome the reluctance many businesses have toward getting involved with the government, said Brad Smith, at the University of Pittsburgh's Center for Biosecurity.

``The question is, are they going to look at what happened here as simply, `Well, you know, VaxGen didn't work out?' Or are they going to look at it and say, `This is just a broken process, government is not a reliable partner and I don't want to touch this."

Drugmakers to receive tax dollars to boost fight against bioterrorism

WASHINGTON — Desperate for vaccines and medicines to ward off deadly threats such as anthrax, Ebola, smallpox and bird flu, Congress wants to give drug companies a new incentive: cash up front.

President Bush signed legislation yesterday that creates a bureaucracy that would give tax dollars to private companies and universities to develop vaccines and treatments.

Scientists would contract with the federal government to take on manmade terrorist threats and naturally occurring pandemics, as well as chemical and radiological threats.

The public-private partnership — akin to the way the Defense Department buys fighter jets — could be a boon for the growing number of biotechnology companies.

But some of the new program’s work also would be shielded from public scrutiny, which critics say could stymie necessary oversight and lend the false impression internationally that the United States is developing biological weapons.

The bill was shepherded through Congress by Sen. Richard Burr, R-N.C., who spent two years fending off critics and trying to shape a new program palatable to biotechnology companies and to Michael Leavitt, the secretary of health and human services.

The law creates the Biomedical Advanced Research and Development Authority. Its director, reporting to Leavitt, would control the money to be distributed for advanced research on a host of vaccines and countermeasures.

The money, $1.07 billion over two years, would be used to help biotechnology companies make the leap from initial research to ready-to-buy procurement.

When the legislation was introduced in 2005, some scientists and advocacy groups were outraged that it would exempt the entire authority from the Freedom of Information Act. No other government agency has such a broad veil of secrecy.

The act signed into law yesterday contains a provision prohibiting disclosure of "technical data or scientific information" that would reveal vulnerabilities of the nation’s defenses that aren’t publicly known. Defining that trigger is up to the secretary of health and human services.

Lynn C. Klotz, a former Harvard University scientist and industry consultant, calls the new, more narrow language better, but still troublesome.

"I’m worried that too much of what they do would still remain secret. I don’t think there’s going to be much oversight," said Klotz, a senior science fellow at the Center for Arms Control and Non-Proliferation in Washington.

He added that other countries could assume that the United States is doing nefarious work. "It’s the extreme secrecy which makes everybody suspicious of us," Klotz said.

Burr said it would be irresponsible to reveal any vulnerabilities to the nation’s defenses. "Where it might provide our enemy some advantage, I think we have a right and commitment to withhold that information from the public," he said.

December 20, 2006

U.S. cancels VaxGen's $877.5 million contract to make anthrax vaccine

In a major setback for the nation's efforts to counter bioterrorism, federal officials Tuesday canceled their $877.5 million contract with Brisbane-based VaxGen for an improved anthrax vaccine, because the company was behind schedule developing it.

The U.S. Department of Health and Human Services sent VaxGen a letter terminating the contract, awarded in March 2004, citing the company's failure to meet a deadline Monday for beginning a key test of the vaccine in people.

The contract had been the largest issued under President Bush's Project BioShield, a $5.6 billion program to counter bioterrorism over 10 years. Under the contract, VaxGen was to have provided 75 million doses of the vaccine, which were to be stockpiled for civilian use in case of an anthrax attack on the country.

VaxGen had conducted several tests of the vaccine earlier. But the U.S. Food and Drug Administration had refused to let the one scheduled for Monday begin. The FDA feared the vaccine was proving unstable and might lose its potency, rendering the study results unreliable.

``VaxGen's failure to perform is not excusable,'' said the letter from the Department of Health and Human Services. ``The government is terminating the contract for default.''

VaxGen spokesman Lance Ignon expressed dismay over the federal agency's action and said the company was considering appealing the decision.

``We certainly knew that this was a strong possibility, but we are still obviously very disappointed,'' he said. ``VaxGen made an enormous investment in this vaccine,'' he added, noting that it spent more than $175 million of its own money developing the vaccine. Under the contract, the company would only receive the $877.5 million after the vaccine was delivered to the government.

``It's regrettable that HHS chose not to engage with us to explore options'' about how to continue developing the vaccine, Ignon said. ``We asked them repeatedly through as many channels as we could possibly pursue to have an open and productive dialogue with us, and they refused.''

Having its biggest contract terminated could be a serious blow to the company. VaxGen also is working on a smallpox vaccine, which it hopes to persuade the federal government to buy. But the agency likely to be involved in purchasing it would be the same agency that canceled the anthrax vaccine contract.

Moreover, the federal government's termination letter to VaxGen warned that the company may be ``held liable for any excess costs.'' The letter didn't explain what those costs might be. But if the government has to buy another anthrax vaccine at a higher per-dose cost than what VaxGen's contract called for, the government could order VaxGen to pay the difference, Ignon said.

The government had been getting antsy about the vaccine contract for some time. VaxGen was at least a year behind schedule, and it has been in a nasty spat in recent months with the Department of Health and Human Service over the terms of the contract.

VaxGen has acknowledged that the vaccine has had stability problems, but it has said in the past that it thought the problem had been fixed.

Health and Human Services spokesman Bill Hall said he couldn't comment on the agency's options for developing an improved anthrax vaccine.

``It's impossible for me to speculate on what our next steps will be,'' he said. But he added, ``we are still fully committed to the development of a next generation anthrax vaccine. That remains unchanged.''

Since Sept. 11, federal officials have been especially worried about terrorists launching an anthrax attack. The bacteria is relatively easy to obtain, can be dispersed over a wide area and secretes proteins that become highly toxic when they come in contact with human cells.

Although federal officials had considered VaxGen's vaccine promising, critics in Congress and elsewhere questioned why the small company won the contract in the first place. VaxGen has no commercial products, failed at making an AIDS vaccine and has been delisted from the Nasdaq Stock Market since 2004 because of its fouled-up financial records.

Yet because most other vaccine companies declined to bid on the contract, the government had few other options.

The United States already has an anthrax vaccine, AVA. Developed in the 1950s, it has been used to inoculate more than 1 million military personnel. But AVA has been linked to six deaths and unpleasant side effects, from fever to body aches. Hundreds of soldiers have refused to take it.

AVA also must be given in a series of six shots over an 18-month period, which health officials consider complicated. The amount of its protective antigen also varies from one production lot to another. Federal officials had hoped VaxGen's genetically engineered vaccine would provide a more consistent amount of protection and require only three doses.

Since VaxGen began having problems with its vaccine, the federal government ordered 10 million doses of AVA to bolster the civilian stockpiles. Hall said he couldn't comment on whether his agency might purchase additional doses of AVA.

Kim Brennen Root, spokeswoman for Emergent BioSolutions of Maryland, which makes AVA, said her company would provide the government more doses of its vaccine if needed. ``We are prepared to act, should HHS call on us,'' she said.

DHHS cancels new vaccine, but DoD's old anthrax vaccine has never been tested on humans either

DHHS cancels new vaccine, but DoD's old anthrax vaccine has never been tested on humans either...

Reuters reports: Federal health officials canceled an $877.5 million contract with VaxGen to develop an anthrax vaccine, a key component of an administration program to counter bioterrorism, after the company missed a deadline to begin human testing.

Proposed Rule, 50 FR 51002: Ref the old anthrax vaccine - "The vaccine manufactured by the Michigan Department of Public Health has not been employed in a controlled field trial."

GAO Report T-NSIAD-99-148: Ref the old anthrax vaccine - "long-term safety of the vaccine has not yet been studied" "vaccine and the manufacturing process (was) changed" ....... "the ingredients used to make vaccine were changed from the original vaccine" ... "Prior to the time of licensing, no human efficacy testing of the MDPH vaccine was performed."

Anthrax Vaccine Contract Voided, Thwarting Administration

Federal health officials yesterday scuttled the largest piece of the Bush administration's two-year program to counter bioterrorism, canceling an $877.5 million contract with VaxGen to develop an anthrax vaccine after the company missed a deadline to begin human testing.

The decision, delivered in a one-page letter, ends a troubled effort by the small California firm that has come to symbolize the failures of the government's ambitious $5.6 billion Project BioShield. The termination occurred on the same day President Bush signed legislation attempting to salvage the program by reorganizing its management and pumping more money into firms doing the work.

"It's very disappointing that they took such aggressive and dramatic action without engaging in a discussion with us about potential ways for salvaging all the work that has gone into this program," said Lance Ignon, VaxGen's vice president of corporate affairs. "We believe there is a high probability that this technology would lead to a modern anthrax vaccine."

The company has spent more than $175 million of its own money on the project, its only current contract, he said.

The cancellation means the government will continue to depend on a controversial anthrax vaccine, used by the military and made by Emergent BioSolutions of Gaithersburg, years longer than expected. A spokesman for the Department of Health and Human Services said the agency remains committed to developing a next-generation anthrax vaccine but has not decided whether to hold another competition.

"We are moving as aggressively and quickly as we can to reach that goal," said Bill Hall, a department spokesman.

VaxGen was picked for the project in 2004 despite having never successfully produced a drug. It was known for a failed attempt at an AIDS vaccine, and the company has had accounting and management problems, which caused it be delisted from the Nasdaq Stock Market.

In signing on to develop an anthrax vaccine, the company agreed to meet the government's aggressive timetable, producing a drug in five years, half the industry standard for such a product. VaxGen was to be paid as it began delivering the 75 million doses to the government, enough for 25 million people, roughly the equivalent of the population in the New York and Washington areas combined.

But VaxGen struggled from the beginning. The product's expected delivery was delayed two years as the company attempted to improve the vaccine's potency and reliability. In November, the company suffered another blow when the Food and Drug Administration refused to allow the firm to begin human testing because of those long-standing concerns.

The cancellation throws the company's survivability into doubt. VaxGen has said it has enough funds to work through 2007, but its only other product is a smallpox vaccine for which it doesn't have a contract. The anthrax contract was canceled for default, meaning the government does not plan to reimburse VaxGen for its costs and could even hold the company liable if there are extra costs from buying the product from another source.

VaxGen is exploring its legal and strategic options, Ignon said. The company could appeal the decision. "Fortunately, we are well capitalized," he said.

The government now hopes a reorganization of the program, signed into law yesterday, will address the delays and other complaints lobbed at Project BioShield by the private sector for the past two years. The legislation creates the Biomedical Advanced Research and Development Authority, within HHS, to manage the effort. It also allocates $1 billion over three years for research and attempts to pump more government money into the private sector sooner by making payments as companies meet milestones, instead of waiting until they begin delivering the product.

Yesterday's cancellation of the VaxGen effort "is a step back for an anthrax vaccine, but I think we have said this was a flaw in BioShield," said Sen. Richard Burr (R-N.C.), one of the chief architects of the legislation revamping the program. "I would like to think if that happened under the new system, we would have caught the problem at a much earlier point."

Until a new vaccine is developed, the government will rely on its stockpiles of antibiotics, including ciprofloxacin, for dealing with anthrax exposure and 10 million doses of an older vaccine made by Emergent. Some soldiers have complained of significant side effects from the Emergent vaccine and have refused to take it, though the FDA says it's safe. VaxGen had aimed to require fewer doses over a shorter period than Emergent's to produce immunity.

GAITHERSBURG, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE:EBS), a leader in biodefense medical countermeasures, today applauded Congress and President Bush as he signed into law the Pandemic and All-Hazards Preparedness Act, which authorizes appropriations through 2011 to improve bioterrorism and other public health emergency planning and preparedness activities and creates the Biomedical Advanced Research and Development Authority, or BARDA, under the direction of the Department of Health and Human Services, which will be focused on directing advanced research and development of vaccines and therapeutics for use against biological attacks.

“I congratulate Congress on passing this comprehensive legislation and the President for signing it into law. It is an important signal to the biopharmaceutical industry regarding the government’s commitment to access effective bioterror countermeasures,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “This legislation should enable the U.S. Government to better develop, procure and make available countermeasures that can help protect Americans in a public health emergency. With a more streamlined procurement process and the establishment of a National Biodefense Science Board, among other items, the BARDA bill is clearly a significant and positive step forward in strengthening our nation’s bio-security strategy.”

Among the products in its biodefense product portfolio, Emergent BioSolutions manufactures and sells BioThrax® (Anthrax Vaccine Adsorbed), the only vaccine licensed by the FDA for the prevention of anthrax, and is developing an anthrax immune globulin, a botulinum vaccine and a botulinum immune globulin. The Company is also developing commercial vaccines to help fight infectious disease with unmet or underserved medical needs.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics. Immunobiotics are vaccines and immune globulins that induce or assist the body’s immune system to prevent or treat disease. The company’s biodefense business is focused on developing and commercializing immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company’s commercial business is focused on developing immunobiotics for use against infectious diseases with significant unmet or underserved medical needs. More information on the company is available at www.emergentbiosolutions.com.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our plans for future sales of BioThrax®; our plans to pursue label expansions and improvements for BioThrax®; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs; preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Registration Statement on Form S-1 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

December 19, 2006

Bush Signs BARDA

http://www.guardian.co.uk/worldlatest/story/0,,-6291080,00.html

WASHINGTON (AP) - President Bush on Tuesday signed bills to raise federal funding for autism, shift AIDS money to rural areas and the South and create a government unit to oversee response to a bird flu pandemic or bioterrorism attack.

The autism bill increases federal funding by 50 percent for the disorder, which afflicts 1.5 million people in the United States.

Congress voted on Dec. 7 to significantly increase federal funding to identify the cause of autism, now diagnosed in one in 166 children. The Senate, acting a day after House passage, approved on a voice vote legislation that authorizes $945 million over five years for autism research, screening and treatment.

The legislation provides the National Institutes of Health with a list of possible research areas related to autism spectrum disorder, including an examination of whether the increase in autism diagnoses is caused by environmental factors.

The AIDS legislation Bush signed will shift care and treatment money to rural areas and the South.

The House on Dec. 9 agreed by voice vote to renew the $2.1 billion-annual Ryan White CARE Act. The Senate passed the bill earlier after senators from New York and New Jersey dropped their opposition, accepting a compromise that settled months of dispute just as Congress adjourned for the year.

Lawmakers from some urban areas feared losing money under a five-year renewal of the law. The final deal renews it for three years. That allows earlier reviews of the formulas for distributing money and eliminates the large dollar cuts in the final years that threatened some areas.

AIDS began as a big-city epidemic affecting mainly gay white men. The updates, the first since 2000, aim to spread money more equally around the country. Current law had only counted patients with full-blown AIDS. The revision also counts patients with the HIV virus who have not developed AIDS. That change favors the South and rural areas, for example, where the disease is a newer phenomenon.

The president also signed a bill to create a new agency within the Health and Human Services Department to oversee the development of medicine and equipment to respond to a bird flu pandemic or a bioterrorism attack. --- The bills are: Combating Autism Act of 2006 S. 843 Pandemic and All-Hazards Preparedness Act S. 3678 Ryan White HIV/AIDS Treatment Modernization Act of 2006 H.R. 6143 On the Net: Congress: http://thomas.loc.gov/

December 18, 2006

Class Action Suit Targets Anthrax Vaccine

Two years after an earlier lawsuit temporarily halted mandatory anthrax vaccinations for all 2.4 million U.S. military service members and some military contractors, another group of military service members and Pentagon civilian contractors are going to federal court to block the vaccine's forced use.

Six complainants, remaining unidentified to protect them from retaliatory military discipline, filed suit against federal military and health officials Dec. 13 in U.S. District Court for the District of Columbia. They're asking a judge once again to declare the controversial vaccine an unapproved drug and unlawful for use without informed consent.

Connecticut's U.S. Rep. Christopher Shays, R-Stamford, state Attorney General Richard Blumenthal and two well-known Connecticut U.S. Air Force officers, Thomas Rempfer and Russ Dingle, were leading opponents of the inoculation program when it began in 1997. For seven years, in vain, they pressured Congress, two presidents and high-ranking Pentagon officials to halt the program. Lt. Col. Dingle, of East Hartford, died in September 2005.

A federal court order in late 2004 halted mandatory vaccinations based on a finding that the Food and Drug Administration failed to follow licensing regulations. But soon after the FDA issued a final order approving the vaccine's safety and effectiveness in December 2005, the Department of Defense announced it was reinstituting the mandatory inoculation program for those serving in Korea and the Middle East.

Critics charge the FDA failed to provide evidence the vaccine was effective against inhalation (weaponized) anthrax, and failed to address reports of adverse health consequences from the vaccine.

Reached last week, Blumenthal said he hasn't yet reviewed the class action. But he seemed to place little confidence in the FDA final rule. "My belief has been consistently that the vaccine should be voluntary unless and until a new vaccine is developed that is safe and effective," he said.

Shays agreed. Military personnel "volunteer to put on the uniform to defend us. They should not be required to put untested vaccines into their bodies," he said.

Each of the plaintiffs faces either termination from employment or criminal prosecution if they refuse inoculation.

Adverse Reactions

The U.S. Government Accountability Office reported that the vaccine's systemic adverse reaction rate was 100 times higher than the 0.2 percent rate reported on the product's label. Adverse vaccine reactions were said by users to include immune disorders, muscle and joint pains, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to use of the vaccine, but they have not been definitively proven as linked.

Chicago attorney John J. Michels Jr., co-counsel in the litigation with D.C. attorney Mark S. Zaid, charged, "FDA's certification of the vaccine â€¦ is based on slipshod statistical analysis, and an improper use of testing data. [That], as well as the defense department's alteration of the vaccine dosing schedule, renders [it] a drug unapproved for its applied use under current federal law."

Defense department and FDA spokespersons declined to comment on the pending litigation, but maintained the safety and effectiveness of the vaccine. "We believe, in issuing its final order last December, the FDA affirmed once and for all the safety and efficacy of our vaccine," said Kim Brennen Root, a spokeswoman for BioPort Corp., the vaccine's manufacturer.

Nearly 500 active-duty service members have refused the vaccine, and more than 100 have been court-martialed. Additionally, approximately 500 to 1,000 pilots and flight crew members have quit, resigned or transferred from the Air National Guard or Reserves rather than take the vaccine. The vaccine is voluntary in the Australian, British and Canadian militaries, as well as for U.S. Department of State employees, even though they serve in the same geographical region as that of U.S. military service members.

FDA Maintains Clinical Hold on VaxGen's Anthrax Vaccine Trial

BRISBANE, Calif., Dec. 18 /PRNewswire-FirstCall/ -- VaxGen, Inc. (Pink Sheets: VXGN.PK - News) announced today that the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has informed the company that it is maintaining its clinical hold on the company's second Phase II trial for its investigational anthrax vaccine. The hold is due to CBER's continued concerns about the vaccine candidate's stability.

The Department of Health and Human Services (HHS), under its contract with VaxGen to purchase 75 million doses of its recombinant anthrax vaccine, rPA102, had imposed a deadline of today, December 18, for the company to initiate its next clinical trial for the vaccine candidate. The Office of Public Health Emergency Preparedness (OPHEP), the office within HHS that administers the contract, has yet to inform VaxGen what direction it intends to take with respect to the contract.

At a recent meeting with CBER, which was also attended by OPHEP representatives, VaxGen presented its expanded number of methods for measuring the vaccine's potency and stability, and its progress toward further enhancing the stability of the vaccine's formulation. Based on that exchange, VaxGen believes that CBER wishes to engage the company in additional, more detailed technical discussions about the analytical methods and formulation development. However, the clinical hold will remain in place until sufficient vaccine stability has been demonstrated to resume clinical testing.

About VaxGen

VaxGen, Inc. is a biopharmaceutical company engaged in the development, manufacture and commercialization of biologic products for the prevention and treatment of human infectious diseases, including anthrax and smallpox. VaxGen has been awarded an $877.5 million contract by HHS to provide 75 million doses of a modern anthrax vaccine for civilian biodefense. Based in Brisbane, Calif., VaxGen operates a wholly owned manufacturing facility in California and owns a minority interest in Celltrion, Inc., a company in the Republic of Korea established to provide contract manufacturing to the global pharmaceutical industry. For more information, please visit the company's web site at www.vaxgen.com.

Note: This press release contains "forward-looking statements" within the meaning of the federal securities laws. These forward-looking statements include, without limitation, statements regarding VaxGen's ability to address FDA/CBER's concerns over vaccine stability, to resolve the clinical hold imposed by FDA/CBER and to perform under its contract with HHS. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Item 8.01 of the company's Current Report on Form 8-K filed by VaxGen on February 16, 2006 under the heading "Risk Factors" for a more detailed description of such risks. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. VaxGen undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.

Vaccine ruined his health, career, former airman claims

By Gayle S. PutrichStaff writer

When Staff Sgt. Jason Adkins joined the Air Force, he never expected to end up a pariah. Especially not when he followed orders to the letter.

In 1998, Adkins, a C-5 flight engineer, was transferred to Dover Air Force Base, Del., and ordered to take the anthrax vaccine. Other service members and civilian employees refused the inoculations, but Adkins wasn't one of them.

Between September 1998 and October 2004, he received eight shots ” the initial six-shot regimen and two boosters" which he said subsequently left him with debilitating side effects.

When he tried to speak out about a possible link between his health problems and the vaccine, he said, his chain of command came down on him hard and left a promising 14-year military career in shambles.

An untold number of troops were punished for refusing the anthrax vaccine from 1998 through late 2004 ” the exact number is unknown, but certainly at least hundreds" but Adkins' case is an unusual twist on the legal issues related to the anthrax vaccine.

Adkins has fought back, suing the government in federal court in Delaware to have his records corrected and a letter put in his personnel file stating that his free-speech rights were violated.

Twice, the Defense Department has asked a judge to throw out the case, and twice the request has been denied, most recently in August, said Stephen Neuberger, Adkin's attorney.

Before taking the anthrax vaccine, Adkins was the fitness monitor for his flight squadron, able to bench-press 425 pounds and the picture of health.

"I was the textbook person for the Air Force in the flight suit," he said.

When he was ordered to take the shots, Adkins said he trusted that the military was doing it for his own good. But symptoms crept up on him, he said, as he went through the shot regimen.

His lawsuit says six of his shots were "tainted with squalene," a vaccine additive that can boost immune response but can cause serious side effects and is not approved for human use by the Food and Drug Administration.

In late 2000, the FDA found traces of squalene in five lots of anthrax vaccine delivered to Dover. The Pentagon has denied deliberately adding squalene to any stocks of the vaccine and said its trace presence in the Dover lots was an accident.

He was afraid to discuss any of his problems for fear of being permanently grounded. "Flying was my world," he said.

But on the night before a mission in October 2004, he came down with a migraine headache so severe that "he felt his health would endanger the lives of his crew, the mission and the aircraft," court documents state.

Adkins finally went to his flight surgeon, who indeed grounded him. Within hours, documents state, his commanders accused him of dereliction of duty and of faking his migraines so he wouldn't have to fly, banned him from wearing his flight suit and wings and issued him a written reprimand.

"They came down on him, and they came down on him hard, Neuberger said.

Lawyers for the government argued that Adkins has not demonstrated that he was singled out for retaliation and that he has not exhausted all military administrative options. On the question of the violation of Adkin's free speech, they argued that what he said was not a matter of public concern and that the military's need to maintain "the obedience of its enlisted personnel" trumped Adkin's right to free speech.

Defense Department officials declined to comment on the case because it is pending.

The Pentagon's anthrax vaccine Web site, www.anthrax.osd.mil, has an "adverse events" section that instructs those who think they are having a negative reaction to the vaccine to "go to their health care provider as soon as possible."

According to the site, it is the patient's responsibility to ask the health care provider to file a report with the Vaccine Adverse Event Reporting System, a Health and Human Services Department database.

The FDA said in late 2005 that from July 1990 through March 2005, VAERS logged 4,279 reports of health problems as a result of the anthrax vaccine, with 390 listed as "serious."

But critics claim the number of adverse events is higher, and even the FDA acknowledges the "passive" nature of VAERS may lead to underreporting. There is no requirement that reactions to the inoculations be reported, to VAERS or anyone else.

The Pentagon has established a national Vaccine Healthcare Centers Network, with a hub based at Walter Reed Medical Center in Washington, D.C.

The VHC is designed to act as a "specialized clinical support system for the development and implementation of programs, research and services that enhance vaccine safety, efficacy and acceptability," according to its Web site.

Despite repeated requests, officials at Walter Reed would not make doctors available to Air Force Times to discuss documentation, tracking and rates of adverse reactions to the anthrax vaccine.

The VHC's main Web page - www.vhcinfo.org/index.htm - does not seem to have been updated in almost a year. At press time, it featured a Dec. 19, 2005, announcement that the FDA had issued a final order finding the vaccine to be effective against all forms of anthrax, stating that the vaccination program would remain voluntary until further notice and that the policy was under review by "senior civilian leaders."

Meanwhile, the man whose world revolved around flying now runs a lawn care business in Delaware.

His problems are chronic, and while the symptoms may become manageable over time, Adkins said, they'll never go away. Doctors have told the 30-year-old that he has the hip joints of a 50-year-old.

"You just learn to deal with it," he said.

He also said he lives with deep disappointment at how the military treats those who dare to even suggest they may have been sickened by a vaccine that was supposed to protect them.

"Walk into any military hospital and say "anthrax vaccine," and it's like you pulled a fire alarm," Adkins said. "I was their textbook kid, a golden boy - until I mentioned that word."

Critics question safety of vaccine additives

By Gayle S. PutrichStaff writer

A persistent criticism from opponents of the Pentagon's anthrax vaccination program is the charge that defense officials purposely put squalene in some vaccine lots to boost troops' immune responses and increase the length of time vaccine stocks would remain effective.

The Pentagon and the vaccine's manufacturer have repeatedly denied those charges, but opponents continue to question whether the fatlike substance may have played a role in illnesses developed by some troops who got anthrax shots during the 1991 Persian Gulf War and in the early stages of the Pentagon's mandatory anthrax vaccine program in the late 1990s.

Although squalene occurs naturally in the human body, some scientists say injecting even small amounts can cause illness.

Now, a study is drawing attention to another anthrax vaccine additive with possible serious side effects - aluminum hydroxide, a substance routinely added to many common vaccines to spur production of antibodies, though scientists are not sure how it does that.

Defense officials acknowledge the vaccine contains aluminum hydroxide, which the Federal Drug Administration considers safe for use in vaccines in small amounts. But a study to be published in the February 2007 issue of Neuromolecular Medicine says aluminum hydroxide at levels normally found in vaccines killed neurons in the brains of mice and sparked serious side effects.

The squalene battle

Squalene, a cholesterol-building compound, is produced naturally by the body in small amounts.

A Pentagon-initiated test by Stanford Research Institute International conducted between May 1999 and September 2000 found no squalene in the anthrax vaccine.

In late 2000, the FDA announced it had found traces of squalene in five lots of anthrax vaccine. All had been sent to Dover Air Force Base, Del., where scores of pilots reported muscle aches, memory loss, headaches, severe fatigue and other symptoms after being ordered to take the shots in 1999.

Defense officials have insisted the presence of squalene in those lots was accidental.

"The level ... identified by the FDA test is so minute that it is likely the result of squalene in the oil of a fingerprint not cleaned from lab glassware," states the Pentagon's anthrax vaccine Web site, www.anthrax.osd.mil.

But then-base commander Col. Felix Grieder told the media as recently as 2004 that he believed his airmen were used as guinea pigs for illegal medical experiments.

A 1999 Tulane University study also found squalene antibodies in veterans of the 1991 Gulf War who had received anthrax shots.

No medical study ever has pointed to a conclusive cause of the symptoms collectively known as Gulf War illnesses. But participants in the 1999 Tulane study all had similar symptoms and the same squalene antibodies in their blood - even those who never actually deployed to the Persian Gulf.

In the study to be published in February, a collaboration by one American and four Canadian scientists, mice were injected with two doses of adjuvants, chemicals that boost immune response, at a level normally expected in vaccines, scaled down to mouse-sized proportions.

Some mice received aluminum hydroxide, some got squalene, and others received both.

"The greatest overall effects were seen in mice injected with aluminum hydroxide," the study states. The substance killed brain neurons and led to - progressive and significant decrease in muscular strength and endurance, - loss of long-term memory and motor control, and behavioral problems.

Researchers also compared the symptoms of veterans suffering from Gulf War illnesseses and amyotrophic lateral sclerosis "Lou Gehrig's disease" with the symptoms observed in mice given aluminum hydroxide.

In addition to spinal cord problems, the mice suffered neuron death in the same parts of the brain affected in human motor-function diseases like ALS and Parkinson's. Several studies have shown an above-average incidence of ALS among Gulf War veterans.

"These results are consistent with a potential role for aluminum in motor neuron death in ALS," the study says.

The researchers acknowledge that variables such as stress, multiple vaccinations and exposure to other toxins could cause or intensify negative reactions to adjuvants.

But they also say even the possibility of negative effects from aluminum hydroxide suggests that its use in anthrax vaccine and other vaccines for the military and the general public should be reconsidered and studied further.

"Whether the risk of protection from a dreaded disease outweighs the risk of toxicity is a question that demands urgent attention," the study says.

At press time, Defense Department officials had not responded to several requests for comment on the study.

Anthrax shots are back - Vaccinations are mandatory again. Here's what you should know

By Gayle S. PutrichStaff writer

Get ready, because here they come - mandatory anthrax vaccinations are back.

Since December 2004, the vaccine has been optional for all troops, no matter where they deployed or what their job, in the wake of a court ruling that halted the original mandatory program.

But with the Food and Drug Administration having issued a final rule declaring the vaccine safe and effective against all forms of anthrax, defense officials say the shots will again be required starting early next year for anyone assigned to U.S. Central Command, including Iraq and Afghanistan, or U.S. Forces Korea.

Here's what you need to know, from when the Pentagon expects to start vaccinations to what you should do if you have a bad reaction to the shots.

"The threat of biological warfare has been a risk to U.S. forces for many years, and the threat of anthrax weapons in the hands of adversarial countries remains strong," officials said.

Q. Who will be required to take the shots under the new mandatory program?

A. The policy announced in October directs mandatory anthrax shots for troops, emergency-essential civilians and Defense Department contractors carrying out mission-essential services in the Central Command area or South Korea for 15 consecutive days or more. Also, some personnel assigned to special mission units, such as forward-deployed forces and biodefense units, will be required to be vaccinated.

Q. How are National Guard and reserve members affected?

A. Reservists due to deploy will follow the same guidelines as active-duty service members who are preparing to deploy or are currently in theater.

Q. When will shots begin and what does the vaccine regimen consist of?

A. Mandatory immunizations will begin once implementation plans from each service have been approved. Defense officials expect that to happen early next year. Until then, anthrax vaccinations remain voluntary.

The vaccine regimen consists of six shots. The second and third come at two-week intervals after the first; the remaining three shots are administered at six, 12 and 18 months after the first shot. Annual booster shots follow.

Q. If someone redeploys out of a high-risk area before the six-shot series is complete, will he continue with the vaccinations?

A. For personnel no longer assigned to a high-threat area or to designated special-mission roles, the vaccinations stop being mandatory, but individuals may continue them voluntarily.

Q. What is the plan for those who began the shots under the previous mandatory program but stopped when the shots became voluntary?

A. Under guidelines issued by the Centers for Disease Control and Prevention, they will not need to restart the series; they can pick up where they left off.

Q. How many people currently in Central Command or Korea have been vaccinated?

A. Defense officials said they do not provide this figure for operational security reasons. In the two years of the voluntary program, defense officials say about half the troops offered the vaccine have taken it.

Q. Have any troops contracted anthrax or died from the disease?

A. The Defense Department has long maintained that Southwest Asia and Korea are "high threat" areas for weaponized anthrax, but to date, no U.S. troops have contracted or died from the disease in an operational environment, officials say.

Q. Have any troops died from taking the anthrax vaccine?

A. Defense officials say they review all serious adverse events after immunization, including deaths where "a strong temporal association with receipt of anthrax or smallpox vaccines" has been identified. "No cases to date have been causally associated with anthrax immunization alone," they said.

Data from the Food and Drug Administration and the CDC indicate at least 21 people have died after taking the anthrax vaccine, although none of those cases reflects a direct cause-and-effect to the vaccine.

In 2003, Army Reserve Spc. Rachel Lacy died after receiving five vaccines, including anthrax vaccine, before deployment. Two independent panels of medical experts said the combination of vaccines probably, but not conclusively, triggered an underlying and undiagnosed immune system disorder that led to her death.

Q. What legal ramifications do troops, civilians and contractors face if they refuse to take the vaccine?

A. Defense officials say service members have a duty to comply with lawful orders, and civilian employees have a duty to comply with terms of employment. "These duties may be enforced by appropriate administrative or disciplinary action," officials said.

Under the previous mandatory program, which ran from late 1998 to late 2004, service members were routinely punished for refusing to take the vaccine. Punishments ranged from letters of reprimand to courts-martial and dismissal from service.

Q. Is the vaccine safe?

A. The Defense Department says the vaccine is safe, with an "adverse event profile" comparable to other vaccines.

The FDA issued a report on adverse reactions to the anthrax vaccine in December 2005, at about the same time that it made a final ruling on the safety and efficacy of the vaccine. From July 1990 through March 2005, the government-sponsored Vaccine Adverse Event Reporting System logged 4,279 reports of health problems as a result of anthrax vaccine, 390 of which were classified as "serious".

But critics of the vaccine have claimed the number of adverse events is actually much higher, and even the FDA acknowledges the voluntary nature of VAERS may lead to underreporting.

The Pentagon assured Congress that hospitalizations and other serious events following anthrax vaccination would be reported to VAERS, one of the few available public sources for vaccine safety information. But an investigation last December by the Hampton Roads (Va.) Daily Press found that 20,765 hospitalizations that met the VAERS definition of a "serious adverse event" following anthrax vaccination were not reported during that time.

In addition, a review of all data in the VAERS system for every vaccine licensed in the U.S. that was published in a peer-reviewed medical journal in 2004 found that the reported adverse-reaction rate for anthrax vaccine was higher in every category compared to other vaccines.

Q. What are the possible side effects of the anthrax vaccine?

A. The Pentagon says that like all vaccines, anthrax vaccine may cause minor reactions such as soreness, redness, itching, swelling and lumps at the injection site. About 30 percent of men and 60 percent of women report these local reactions, but they usually last only a short while. Lumps can persist a few weeks, but eventually disappear.

Beyond the injection site, between 5 percent and 35 percent of people will notice muscle aches, joint aches, headaches, rash, chills, fever, nausea, loss of appetite, malaise or related symptoms. Officials say these symptoms also usually go away after a few days.

Officials said serious events requiring hospitalization are rare, occurring about once per 200,000 doses. "Severe allergic reactions can occur after any vaccination, at an average rate of less than once per 100,000 doses," they said.

The Defense Department's Vaccine Healthcare Centers can help individuals or health care providers with expert advice on adverse reactions via a secure e-mail consultation system at https://askvhc.wramc.amedd.army.mil or by calling toll-free (866) 210-6469.

Some troops have developed serious illnesses after taking the shots, although their conditions have never been definitively linked to the vaccine. These illnesses have included cysts, blood clots, Lou Gehrig's disease and cancer.

Q. What should service members do if they think they are having an adverse reaction?

A. Officials say adverse events should be evaluated, and if necessary, treated by a health care provider. "It is important for an individual seeking medical attention to inform their health care provider of vaccines they recently received," officials said.

The Vaccine Healthcare Centers can help file a report with the Vaccine Adverse Event Reporting System, document a medical exemption if needed, and manage any ongoing medical problems, to include assistance with access to specialty care.

If at any time a service member feels he is having unusual symptoms, he can contact the Vaccine Heathcare Center and/or file a Vaccine Adverse Event Reporting System report at http://vaers.hhs.gov/.

Q. If troops suffer minor reactions to the vaccine early in the shot series, will they be expected to continue the shots?

A. If an individual experiences a minor reaction to the vaccine early in the series of shots, officials say the service member will continue the series but should avoid strenuous exercise for 24 to 48 hours after the next dose to avoid aggravating a local reaction.

If symptoms worsen, service members are encouraged to seek medical care, document the problems and get an evaluation for either a temporary or permanent medical exemption.

Q. Will an adverse reaction in a service member prior to deployment prevent him from deploying?

A. Officials say that since the majority of adverse reactions are minor and temporary, they will not exempt someone from deployment. But serious adverse events or prolonged, worsening side effects "may result in a medical exemption from continued immunization with the specific vaccine associated with the problem," officials said.

"Medical readiness for deployment involves multiple factors and is related to service and operational specific needs. Vaccines represent only one part of many parameters considered for deployability."

Q. Should a service member have an adverse reaction in the field, particularly in a forward-deployed area, what happens? Will he be sent home?

A. Defense officials say anyone experiencing an adverse event should immediately contact the nearest health care provider. "If the adverse reaction requires emergency medical services, the individual may be taken to the nearest medical facility for evaluation and treatment as required," they said.

Q. Has squalene ever been used in the military's anthrax vaccine? Is it currently being added to the anthrax vaccine?

A. Critics of the military's program have long charged that the Pentagon has used the naturally occurring substance squalene to boost the anthrax vaccine's immune response, and that squalene may be a factor in the mysterious illnesses that have afflicted many veterans of the 1991 Persian Gulf War.

The FDA found trace amounts of squalene in five lots of the vaccine in 2000. But defense officials say neither they "nor anybody else" deliberately added squalene to the vaccine used for U.S. troops.

"Since 1999, four civilian panels have investigated the allegations the squalene was added to the vaccine and repeatedly found them groundless," they said.

The amounts found in the five lots of vaccine were so small that they could have been caused by a human fingerprint left uncleaned on laboratory glassware, defense officials have said.

The anthrax vaccine does contain aluminum hydroxide, which is widely used in many vaccines to enhance antibody production.

Q. Is this the same vaccine used in the Pentagon's original mandatory program?

A. Yes, officials say, "This vaccine has been licensed by the FDA since the 1970s. Based on human and animal data, the National Academy of Science's Institute of Medicine concluded in March 2002 that this anthrax vaccine is "an effective vaccine for the protection of humans against anthrax, including inhalational anthrax, caused by all known or plausible engineered strains of Bacillus anthracis."

"The FDA accepted the panel's recommendation in December 2005, stating that the vaccine is effective in preventing anthrax disease, regardless of the route of exposure."

However, opponents of the program say the vaccine was originally developed to protect mill workers handling infected animal hides and some laboratory workers from the skin form of anthrax. They note there has never been a clinical trial in humans to test the vaccine's effectiveness against inhalation anthrax.